A study protocol of a comparative mixed study of the T-Control catheter.

Background: Foley catheters have been subject to limited development in the last few decades. They fulfil their basic function of draining urine from the bladder but cause other associated problems. T-Control is a new silicone Foley catheter with an integrated fluid control valve whose design aims to reduce the risks associated with bladder catheterization by a multifactorial approach. The general purpose of this study is to determine the effectiveness, comfort, and experience of the patient catheterized with T-Control® compared with patients with a conventional Foley catheter. Study Design: This trial is a mixed-method study comprising a two-arm, pilot comparative study with random allocation to T-Control catheter or traditional Foley catheter in patients with long-term catheterization and a study with qualitative methodology, through discussion groups. Endpoints: The comfort and acceptability of the T-Control® device (qualitative) and the quality of life related to self-perceived health (quantitative) will be analysed as primary endpoints. As secondary endpoints, the following will be analysed: magnitude and rate of infections (symptomatic and asymptomatic); days free of infection; indication of associated antibiotic treatments; determination of biofilm; number of catheter-related adverse events; use of each type of catheterization's healthcare resources; and level of satisfaction and workload of health professionals. Patients and Methods: Eligible patients are male and female adults aged ≥18 years, who require a change of long-term bladder catheter. The estimated sample size is 50 patients. Patient follow-up includes both the time of catheter insertion and its removal or change 4 weeks later, plus the time until the discussion groups take place.

The impact of alpha-1 antitrypsin deficiency alleles on lung cancer survival.

Different studies have shown that carrying an alpha-1 antitrypsin (AAT) deficiency allele is an independent risk factor for developing lung cancer (LC). However, to date, little is known regarding whether carrying a deficiency allele may be a prognostic factor in the evolution of LC. A prospective observational study was carried out which consecutively included patients diagnosed with LC in University Hospital "Nuestra Señora de Candelaria" between December 2017 and August 2020. A blood sample was taken from each of the patients in order to determine both AAT serum concentration and genotype. Based on AAT genotype, patients were divided into the deficiency (Pi*≠MM) or non-deficiency (Pi*=MM) group. One hundred and sixty-four patients were included. The average length of follow-up was 13±10 months. Patients were classified as stage I (4.2%), stage II (8.3%), stage III (31.2%) and stage IV (56.3%), according to tumour, node and metastasis (TNM) staging. Twenty-eight patients (17%) were carriers of a deficiency allele (6 Pi*MS, 1 Pi*MZ, 1 Pi*MMheerlen). No significant differences were found with respect to baseline characteristics between Pi*≠MM and Pi*=MM. Patients in the Pi*≠MM group had a higher risk of death in the first 6 months after the LC diagnosis compared to Pi*=MM subjects (HR =2.04; 95% CI: 1.04-4.0; P=0.038). The presence of an AAT deficiency genotype could be a potential prognostic marker in LC. However, larger studies that justify these findings are needed.

Effectiveness of the T-Control catheter: A study protocol.

Background: Foley catheters have been subject to limited development in the last few decades. They fulfil their basic function of draining urine from the bladder but cause other associated problems. T-Control is a new silicone Foley catheter with an integrated fluid control valve whose design aims to reduce the risks associated with bladder catheterisation by a multifactorial approach. The general purpose of this study is to evaluate the effectiveness and cost-effectiveness of the T-Control catheter versus the Foley-type catheter in patients with Acute Urine Retention (AUR). Study design: This is a pragmatic, open, multicentre, controlled clinical trial with random allocation to the T-Control catheter or a conventional Foley-type catheter in patients with AUR. Endpoints: The magnitude of infections will be analysed as a primary endpoint. While as secondary endpoint, the following will be analysed: rate of symptomatic and asymptomatic infections; days free of infection; quality of life-related to self-perceived health; indication of associated antibiotic treatments; determination of biofilm; number of catheter-related adverse events; use of each type of catheterisation's healthcare resources; level of satisfaction and workload of health professionals and acceptability of the T-Control device as well as the patient experience. Patients and methods: Eligible patients are male adults aged ≥50 years, with AUR and with an indication of bladder catheterisation for at least 2 weeks. The estimated sample size is 50 patients. Patient follow-up includes both the time of catheter insertion and its removal or change 2 weeks later, plus 2 weeks after this time when the patient will be called for an in-depth interview.

Effectiveness, safety and costs of the FreeStyle Libre glucose monitoring system for children and adolescents with type 1 diabetes in Spain: a prospective, uncontrolled, pre-post study.

OBJECTIVES: This study aimed to evaluate the effectiveness, safety and costs of FreeStyle Libre (FSL) glucose monitoring system for children and adolescents with type 1 diabetes mellitus (T1DM) in Spain. DESIGN: Prospective, multicentre pre-post study. SETTING: Thirteen Spanish public hospitals recruited patients from January 2019 to March 2020, with a 12-month follow-up. PARTICIPANTS: 156 patients were included. PRIMARY AND SECONDARY OUTCOME MEASURES: Primary: glycated haemoglobin (HbA1c) change. Secondary: severe hypoglycaemic events (self-reported and clinical records), quality of life, diabetes treatment knowledge, treatment satisfaction, adverse events, adherence, sensor usage time and scans. Healthcare resource utilisation was assessed for cost analysis from the National Health System perspective, incorporating direct healthcare costs. Data analysis used mixed regression models with repeated measures. The intervention's total cost was estimated by multiplying health resource usage with unit costs. RESULTS: In the whole sample, HbA1c increased significantly (0.32%; 95% CI 0.10% to 0.55%). In the subgroup with baseline HbA1c≥7.5% (n=88), there was a significant reduction at 3 months (-0.46%; 95% CI -0.69% to -0.23%), 6 months (-0.49%; 95% CI -0.73% to -0.25%) and 12 months (-0.43%; 95% CI -0.68% to -0.19%). Well-controlled patients had a significant 12-month worsening (0.32%; 95% CI 0.18% to 0.47%). Self-reported severe hypoglycaemia significantly decreased compared with the previous year for the whole sample (-0.37; 95% CI -0.62 to -0.11). Quality of life and diabetes treatment knowledge showed no significant differences, but satisfaction increased. Adolescents had lower sensor usage time and scans than children. Reduction in HbA1c was significantly associated with device adherence. No serious adverse effects were observed. Data suggest that use of FSL could reduce healthcare resource use (strips and lancets) and costs related to productivity loss. CONCLUSIONS: The use of FSL in young patients with T1DM was associated with a significant reduction in severe hypoglycaemia, and improved HbA1c levels were seen in patients with poor baseline control. Findings suggest cost savings and productivity gains for caregivers. Causal evidence is limited due to the study design. Further research is needed to confirm results and assess risks, especially for patients with lower baseline HbA1c.

Persistent Respiratory Failure and Re-Admission in Patients with Chronic Obstructive Pulmonary Disease Following Hospitalization for COVID-19.

Background: Chronic obstructive pulmonary disease (COPD) has been associated with worse clinical evolution/survival during a hospitalization for SARS-CoV2 (COVID-19). The objective of this study was to learn the situation of these patients at discharge as well as the risk of re-admission/mortality in the following 12 months. Methods: We carried out a subanalysis of the RECOVID registry. A multicenter, observational study that retrospectively collected data on severe acute COVID-19 episodes and follow-up visits for up to a year in survivors. The data collection protocol includes general demographic data, smoking, comorbidities, pharmacological treatment, infection severity, complications during hospitalization and required treatment. At discharge, resting oxygen saturation (SpO2), dyspnea according to the mMRC (modified Medical Research Council) scale and long-term oxygen therapy prescription were recorded. The follow-up database included the clinical management visits at 6 and 12 months, where re-admission and mortality were recorded. Results: A total of 2047 patients were included (5.6% had a COPD diagnosis). At discharge, patients with COPD had greater dyspnea and a greater need for prescription home oxygen. After adjusting for age, sex and Charlson comorbidity index, patients with COPD had a greater risk of hospital re-admission due to respiratory causes (HR 2.57 [1.35-4.89], p = 0.004), with no significant differences in survival. Conclusion: Patients with COPD who overcome a serious SARS-CoV2 infection show a worse clinical situation at discharge and a greater risk of re-admission for respiratory causes.

Pilot Study on the Relationship between Malnutrition and Grip Strength with Prognosis in Diabetic Foot.

Sarcopenia and malnutrition have been associated in the elderly population with a poor prognosis in wound healing and with other adverse events, such as institutionalization or functional impairment. However, it is not known how these factors influence the prognosis of diabetic foot in the elderly. To answer this question, a prospective observational study of 45 patients over 65 years of age admitted with diagnoses of diabetic foot in a tertiary hospital has been conducted. All patients were assessed at admission and at 3 months after returning home to determine quality of life, pain, mobility and healing, overall hospital stay in relation to the presence of malnutrition (measured by BMI, CIPA scale and analytical parameters at admission of serum proteins and albumin), and sarcopenia measured by grip force, among other geriatric syndromes. The results found a relationship between altered sarcopenia and more pain and poorer quality of life, and altered BMI was related to a lower cure rate and worse mobility at follow-up. This study seems to indicate that, in the elderly population with diabetic foot, malnutrition and sarcopenia should be managed at the same time as the treatment of the diabetic foot itself.

Composición corporal y evolución nutricional en adolescentes con anorexia nerviosa / Body composition and nutritional status changes in adolescents with anorexia nervosa

Introducción: La valoración nutricional en anorexia nerviosa (AN) incluye determinar la composición corporal y monitorizar su evolución a lo largo del periodo de tratamiento. La prueba gold standard para el estudio de la composición corporal es la absorciometría de rayos X de energía dual (DEXA), si bien la bioimpedancia eléctrica (BIA) se postula como una alternativa más accesible, barata, rápida y que no irradia. Material y métodos: Se reclutaron secuencialmente a 33 mujeres adolescentes (11,7-16,3 años) diagnosticadas de AN. Se recogieron parámetros clínicos, antropométricos y analíticos, y se realizó BIA y DEXA a la inclusión en el estudio y a la finalización del mismo con separación media de un año, durante la fase de rehabilitación nutricional. Resultados: Se objetivó mejoría significativa a nivel nutricional, reflejada en la composición corporal obtenida mediante antropometría y BIA. El ángulo de fase aumentó significativamente durante el periodo de seguimiento. Una mayor pérdida ponderal se correlacionó con la presencia de amenorrea secundaria y con una menor densidad mineral ósea en columna. Conclusiones: La BIA es una herramienta útil para la valoración y el seguimiento del estado nutricional en pacientes con AN en edad pediátrica. La DEXA sigue siendo imprescindible para conocer la afectación de la densidad mineral ósea. El papel de hormonas como la leptina está aún por determinar. (AU)

Introduction: Nutritional status assessment in anorexia nervosa (AN) includes the evaluation and monitoring of body composition throughout the treatment period. The gold standard for the study of body composition is dual-energy X-ray absorptiometry (DEXA), although electrical bioimpedance (BIA) is a more accessible, cheaper and faster method that does not involve exposure to radiation. Material and methods: We recruited 33 female adolescents with AN (age, 11.7-16.3 years) by consecutive sampling. We collected data on clinical, anthropometric and laboratory variables. Patients were assessed with BIA and DEXA at inclusion in the study and at the end of the study, with a mean duration of followup of 1 year, during the nutritional rehabilitation phase. Results: There was significant improvement in nutritional status, reflected by the body composition obtained by anthropometric measurements and BIA. The phase angle increased significantly during the followup. Greater weight loss was associated with the presence of secondary amenorrhoea and decreased bone mineral density in the spine. Conclusions: Electrical BIA is a useful tool for assessment and monitoring of nutritional status in paediatric patients with AN. Dual-energy X-ray absorptiometry continues to be essential to assess bone mineral density. The role of hormones such as leptin remains to be elucidated. (AU)

Effects of ozone therapy on anxiety and depression in patients with refractory symptoms of severe diseases: a pilot study.

Background: Patients with refractory symptoms of severe diseases frequently experience anxiety, depression, and an altered health-related quality of life (HRQOL). Some publications have described the beneficial effect of ozone therapy on several symptoms of this kind of patient. The aim of this study was to preliminarily evaluate, in patients treated because of refractory symptoms of cancer treatment and advanced nononcologic diseases, if ozone therapy has an additional impact on self-reported anxiety and depression. Methods: Before and after ozone treatment, we assessed (i) anxiety and depression according to the Hospital Anxiety and Depression Scale (HADS); (ii) the HRQOL (according to the EQ-5D-5L questionnaire), which includes a dimension on anxiety and depression and a visual analog scale (VAS) measuring self-perceived general health. Results: Before ozone therapy, 56% of patients were on anxiolytic and/or antidepressant treatment. Before and after ozone therapy, the anxiety and depression HADS subscales (i) significantly correlated with the anxiety/depression dimension of the EQ-5D-5L questionnaire and (ii) inversely correlated with the health status as measured by the VAS. After ozone therapy, we found a significant improvement in anxiety and depression measured by both the (i) HADS subscales and (ii) EQ-5D-5L questionnaire. Conclusion: The addition of ozone therapy for patients with refractory symptoms of cancer treatment and advanced chronic nononcologic diseases can decrease anxiety and depression severity levels. Additional, more focused studies are ongoing to provide the needed explanatory information for this finding.

Body composition and nutritional status changes in adolescents with anorexia nervosa.

INTRODUCTION: Nutritional status assessment in anorexia nervosa (AN) includes the evaluation and monitoring of body composition throughout the treatment period. The gold standard for the study of body composition is dual-energy X-ray absorptiometry (DEXA), although electrical bioimpedance (BIA) is a more accessible, cheaper and faster method that does not involve exposure to radiation. MATERIAL AND METHODS: We recruited 33 female adolescents with AN (age, 11.7-16.3 years) by consecutive sampling. We collected data on clinical, anthropometric and laboratory variables. Patients were assessed with BIA and DEXA at inclusion in the study and at the end of the study, with a mean duration of follow-up of 1 year, during the nutritional rehabilitation phase. RESULTS: There was significant improvement in nutritional status, reflected by the body composition obtained by anthropometric measurements and BIA. The phase angle increased significantly during the follow-up. Greater weight loss was associated with the presence of secondary amenorrhoea and decreased bone mineral density in the spine. CONCLUSIONS: Electrical BIA is a useful tool for assessment and monitoring of nutritional status in paediatric patients with AN. Dual-energy X-ray absorptiometry continues to be essential to assess bone mineral density. The role of hormones such as leptin remains to be elucidated.

The relationship between patient empowerment and related constructs, affective symptoms and quality of life in patients with type 2 diabetes: a systematic review and meta-analysis.

Introduction: The aim of this systematic review is to assess the relationship between patient empowerment and other empowerment-related constructs, and affective symptoms and quality of life in patients with type 2 diabetes. Methods: A systematic review of the literature was conducted, according to the PRISMA guidelines. Studies addressing adult patients with type 2 diabetes and reporting the association between empowerment-related constructs and subjective measures of anxiety, depression and distress, as well as self-reported quality of life were included. The following electronic databases were consulted from inception to July 2022: Medline, Embase, PsycINFO, and Cochrane Library. The methodological quality of the included studies was analyzed using validated tools adapted to each study design. Meta-analyses of correlations were performed using an inverse variance restricted maximum likelihood random-effects. Results: The initial search yielded 2463 references and seventy-one studies were finally included. We found a weak-to-moderate inverse association between patient empowerment-related constructs and both anxiety (r = -0.22) and depression (r = -0.29). Moreover, empowerment-related constructs were moderately negatively correlated with distress (r = -0.31) and moderately positively correlated with general quality of life (r = 0.32). Small associations between empowerment-related constructs and both mental (r = 0.23) and physical quality of life (r = 0.13) were also reported. Discussion: This evidence is mostly from cross-sectional studies. High-quality prospective studies are needed not only to better understand the role of patient empowerment but to assess causal associations. The results of the study highlight the importance of patient empowerment and other empowerment-related constructs such as self-efficacy or perceived control in diabetes care. Thus, they should be considered in the design, development and implementation of effective interventions and policies aimed at improving psychosocial outcomes in patients with type 2 diabetes. Systematic review registration: https://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42020192429, identifier CRD42020192429.

Preliminary assessment of the degree of food addiction through the Spanish Yale Food Addiction Scale for Children (S-YFAS-C) in a pilot pediatric population.

INTRODUCTION: The Spanish Yale Food Addiction Scale for Children (S-YFAS-C) scale is the first tool adapted to Spanish to evaluate food addiction (FA) in the paediatric population. The aim of this study is to preliminarily evaluate the degree of FA in a non-clinical pilot paediatric population. MATERIAL AND METHODS: A transversal observational study was performed on a convenience sample comprised of boys and girls aged 9 to 12 (4th to 6th year primary school). The main outcome measures were evaluation of FA (S-YFAS-C scale), child feeding attitudes (ChEAT scale) and evaluation of body image (CDRS scale). Moreover, sociodemographic and anthropometric data were collected. A descriptive and bivariate analysis of the main characteristics of subjects and outcome measures was performed. RESULTS: A total of 21 boys and 24 girls were preliminarily evaluated and the minimum and maximum values obtained were for age (9.48-12.33), weight in kilograms (26.6-64.5), height in centimetres (131-163), BMI (14.2-27.9) and BMI Z-score (-1.36-2.66). The average number of FA symptoms measured with the S-YFAS-C scale is 1.67 ± 1.45 (range 0-7). A total of 20% of the sample shows three or more symptoms for FA, risk of developing a food disorder and distortion of the body image. Moreover, statistically significant differences were observed between desired body image in boys and girls (P = 0.001). CONCLUSIONS: The S-YFAS-C scale enables evaluating food addiction in Spanish-speaking boys and girls. The data obtained in regard to quantifying symptoms are similar compared to the original scale (S-YFAS-C: 1.67 ± 1.45 vs. YFAS-C: 2 ± 1.81). The option to score the counting of symptoms is the most sensitive measure to evaluate subclinical food behaviours.

The Spanish Yale Food Addiction Scale for Children (S-YFAS-C) scale is the first tool adapted to Spanish to evaluate food addiction (FA) in the paediatric population. The aim of this study is to preliminarily evaluate the degree of FA in a non-clinical pilot paediatric population. A total of 21 boys and 24 girls were preliminarily evaluated and 20% of the sample shows three or more symptoms for FA, risk of developing a food disorder and distortion of the body image. The S-YFAS-C scale enables evaluating food addiction in Spanish-speaking boys and girls. The data obtained in regard to quantifying symptoms are similar compared to the original scale.

[Scalp cooling for the prevention of chemotherapy-induced alopecia: systematic review and meta-analysis.] / Enfriamiento del cuero cabelludo para la prevención de la alopecia secundaria a quimioterapia: revisión sistemática y metanálisis.

OBJECTIVE: Alopecia is one of the most common adverse effects of chemotherapy, having a significant impact on the quality of life of patients who suffer from it. Among the interventions available for its prevention, scalp cooling (SC) is the most widely used. The aim of this study was to assess the efficacy and safety of the use of SC systems during chemotherapy sessions for the prevention or the reduction of the extent of chemotherapy-induced alopecia. METHODS: A systematic review of the literature published up to November 2021 was carried out. Randomized clinical trials were selected. The main outcome measure was alopecia (hair loss>50%) during and after chemotherapy treatment. When possible, a quantitative synthesis of the results was performed through meta-analysis using the Stata v.15.0 software. The risk ratio (RR) of the variable alopecia, was estimated using a random effects model following the Mantel-Haenszel method. Statistical heterogeneity of the results was evaluated graphically and through the test of heterogeneity χ2 and the Higgins I2 statistic. Sensitivity analyses and subgroup analyses were performed. RESULTS: 13 studies were included, with a total of 832 participants (97.7% women). In most studies, the main chemotherapy treatment applied was anthracyclines or the combination of anthracyclines and taxanes. The results obtained indicate that SC prevents alopecia (loss>50%) by 43% compared to the control group (RR=0.57; 95% CI=0.46 to 0.69; k=9; n=494; I2=63.8%). No statistically significant difference was found between the efficacy of automated and non-automated cooling systems (P=0.967). No serious short- or medium-term adverse events related to SC were recorded. CONCLUSIONS: The results suggest that scalp cooling contributes to the prevention of chemotherapy-induced alopecia.

OBJETIVO: La alopecia es uno de los efectos adversos más comunes de la quimioterapia, con un impacto importante sobre la calidad de vida de los/las pacientes que la padecen. Entre las intervenciones disponibles para su prevención, el enfriamiento del cuero cabelludo (ECC) es la que cuenta con un uso más extendido. El objetivo de este estudio fue evaluar la eficacia y la seguridad del uso de sistemas de ECC durante las sesiones de quimioterapia para la prevención o reducción de la extensión de la alopecia secundaria a la quimioterapia. METODOS: Se llevó a cabo una revisión sistemática de la literatura publicada hasta noviembre de 2021. Se seleccionaron ensayos clínicos aleatorizados. La medida de resultado principal fue la alopecia (pérdida de cabello superior al 50%) durante y posteriormente al tratamiento de quimioterapia. Cuando fue posible, se realizó síntesis cuantitativa de los resultados mediante metanálisis con el programa Stata v.15.0. Se estimó el riesgo relativo (RR) de la variable alopecia, utilizando un modelo de efectos aleatorios siguiendo el método de Mantel-Haenszel. La heterogeneidad estadística de los resultados se evaluó gráficamente y mediante el test de la χ2 y el estadístico I2 de Higgins. Se realizaron análisis de sensibilidad y análisis de subgrupos. RESULTADOS: Se incluyeron 13 estudios con un total de 832 participantes (97,7% de mujeres). En la mayoría de los estudios, los agentes quimioterapéuticos principales aplicados fueron las antraciclinas o la combinación de antraciclinas y taxanos. Los resultados obtenidos indican que el ECC reduce la aparición de la alopecia un 43% frente al grupo control (RR=0,57; IC95%=0,46 a 0,69; k=9; n=494; I2=63,8%). No se encontró una diferencia estadísticamente significativa entre la eficacia de sistemas de enfriamiento automatizados y no automatizados (P=0,967). No se registraron eventos adversos graves a corto o medio plazo relacionados con el ECC. CONCLUSIONES: Los resultados sugieren que el ECC contribuye a prevenir la alopecia secundaria a la quimioterapia.

Enfriamiento del cuero cabelludo para la prevención de la alopecia secundaria a quimioterapia: revisión sistemática y metanálisis / Scalp cooling for the prevention of chemotherapy-induced alopecia: systematic review and meta-analysis

Fundamentos: La alopecia es uno de los efectos adversos más comunes de la quimioterapia, con un impacto importante sobrela calidad de vida de los/las pacientes que la padecen. Entre las intervenciones disponibles para su prevención, el enfriamiento delcuero cabelludo (ECC) es la que cuenta con un uso más extendido. El objetivo de este estudio fue evaluar la eficacia y la seguridaddel uso de sistemas de ECC durante las sesiones de quimioterapia para la prevención o reducción de la extensión de la alopeciasecundaria a la quimioterapia. Métodos: Se llevó a cabo una revisión sistemática de la literatura publicada hasta noviembre de 2021. Se seleccionaron ensayosclínicos aleatorizados. La medida de resultado principal fue la alopecia (pérdida de cabello superior al 50%) durante y posteriormenteal tratamiento de quimioterapia. Cuando fue posible, se realizó síntesis cuantitativa de los resultados mediante metanálisis con elprograma Stata v.15.0. Se estimó el riesgo relativo (RR) de la variable alopecia, utilizando un modelo de efectos aleatorios siguiendoel método de Mantel-Haenszel. La heterogeneidad estadística de los resultados se evaluó gráficamente y mediante el test de la χ2 yel estadístico I2 de Higgins. Se realizaron análisis de sensibilidad y análisis de subgrupos. Resultados: Se incluyeron 13 estudios con un total de 832 participantes (97,7% de mujeres). En la mayoría de los estudios, losagentes quimioterapéuticos principales aplicados fueron las antraciclinas o la combinación de antraciclinas y taxanos. Los resultadosobtenidos indican que el ECC reduce la aparición de la alopecia un 43% frente al grupo control (RR=0,57; IC95%=0,46 a 0,69; k=9;n=494; I2=63,8%). No se encontró una diferencia estadísticamente significativa entre la eficacia de sistemas de enfriamiento auto-matizados y no automatizados (P=0,967). No se registraron eventos adversos graves a corto o medio plazo relacionados con el ECC...(AU)

Background: Alopecia is one of the most common adverse effects of chemotherapy, having a significant impact on the qualityof life of patients who suffer from it. Among the interventions available for its prevention, scalp cooling (SC) is the most widely used. The aim of this study was to assess the efficacy and safety of the use of SC systems during chemotherapy sessions for the preventionor the reduction of the extent of chemotherapy-induced alopecia.Methods: A systematic review of the literature published up to November 2021 was carried out. Randomized clinical trials were selected. The main outcome measure was alopecia (hair loss>50%) during and after chemotherapy treatment. When possible, a quantitative synthesisof the results was performed through meta-analysis using the Stata v.15.0 software. The risk ratio (RR) of the variable alopecia, was estimatedusing a random effects model following the Mantel-Haenszel method. Statistical heterogeneity of the results was evaluated graphically andthrough the test of heterogeneity χ2 and the Higgins I2 statistic. Sensitivity analyses and subgroup analyses were performed. Results: 13 studies were included, with a total of 832 participants (97.7% women). In most studies, the main chemotherapy treat-ment applied was anthracyclines or the combination of anthracyclines and taxanes. The results obtained indicate that SC preventsalopecia (loss>50%) by 43% compared to the control group (RR=0.57; 95% CI=0.46 to 0.69; k=9; n=494; I2=63.8%). No statisticallysignificant difference was found between the efficacy of automated and non-automated cooling systems (P=0.967). No serious short-or medium-term adverse events related to SC were recorded. Conclusions: The results suggest that scalp cooling contributes to the prevention of chemotherapy-induced alopecia.(AU)

Mapping the EQ-5D-5L from the Spanish national health survey functional disability scale through Bayesian networks.

PURPOSE: Preference-based measures are valuable tools for evaluating therapeutic interventions and for cost-effectiveness studies. Mapping procedures are useful when it is not possible to collect these kind of measures. The objective of this study was to evaluate which mapping method is the most appropriate to estimate the EQ-5D-5L index from the Spanish National Health Survey functional disability scale. METHODS: The sample, formed by 5708 older adults (aged 65 years or older), was drawn from the Spanish National Health Survey ("Encuesta Nacional de Salud en España," ENSE in Spanish 2011-2012). The predictions of EQ-5D-5L index were performed with response mapping using Bayesian network (BN), ordered logit (Ologit), and multinomial logistic (ML). The following direct methods were used: ordinary least squares (OLS) and Tobit regression. The intraclass correlation coefficient (ICC), absolute error (MAE), mean squared error (MSE), and root-mean squared error (RMSE) were calculated to compare all models. The predictions of response models were obtained through the expected value method. RESULTS: BN model showed the highest ICC (0.756, 95% confidence interval, CI 0.733-0.777) and lowest MAE (0.110, 95% CI 0.104-0.115). OLS was the model with worse accuracy results with lowest ICC (0.621, 95% CI 0.553-0.681) and highest MAE (0.159, 95%CI: 0.145-0.173). CONCLUSION: Indirect mapping methods (BN, Ologit, and ML) had a better accuracy than the direct methods. The response mapping approach provides a robust method to estimate EQ-5D-5L scores from the functional disability scale.

Effects of Ozone Treatment on Health-Related Quality of Life and Toxicity Induced by Radiotherapy and Chemotherapy in Symptomatic Cancer Survivors.

(1) Background: The continuous improvement in cancer treatment has led to improvement in patients' survival and a subsequent increase in the number of cancer survivors living with adverse side effects of cancer treatments, sometimes with a high and adverse impact on their health-related quality of life (HRQOL). Side effects of cancer treatments are frequently associated with chronic status of oxidative stress, inflammation, and/or ischemia. The potential for ozone treatment to modulate those processes and improve some of those adverse effects has previously been described. The aim of this study was to evaluate the effect of ozone treatment on the HRQOL and grade of toxicity in symptomatic cancer survivors. (2) Methods: Before and after ozone treatment, we assessed (i) the HRQOL (according to the EQ-5D-5L questionnaire) and (ii) the grade of toxicity (according to the Common Terminology Criteria for Adverse Events of the National Cancer Institute of EEUU (CTCAE v.5.0)) in 26 cancer survivors with chronic side effects of radiotherapy and chemotherapy. (3) Results: There was a significant (p < 0.001) improvement in the EQ-5D-5L index as per the self-reported outcome evaluation of patients' health status. All the dimensions of the EQ-5D-5L questionnaire (mobility, self-care, activities, pain/discomfort, and anxiety/depression) and the self-evaluation of the health status using the visual analog scale were significantly improved (p < 0.05). The grade of toxicity was also significantly decreased (p < 0.001). (4) Conclusions: In cancer survivors with chronic side effects of cancer treatment, ozone treatment can improve the grade of toxicity and the HRQOL. These results merit additional research. Further studies are ongoing.

Long-term improvement by ozone treatment in chronic pain secondary to chemotherapy-induced peripheral neuropathy: A preliminary report.

Background: Pain secondary to chemotherapy-induced peripheral neuropathy (CIPN) can limit the administration of chemotherapy, cancer-treatment outcomes, and the quality of life of patients. Oxidative stress and inflammation are some of the key mechanisms involved in CIPN. Successful treatments for CIPN are limited. This report shows our preliminary experience using ozone treatment as a modulator of oxidative stress in chronic pain secondary to CIPN. Methods: Ozone treatment, by rectal insufflation, was administered in seven patients suffering from pain secondary to grade II or III CIPN. Pain was assessed by the visual analog scale (VAS). Results: All patients, except one, showed clinically relevant pain improvement. Median pain score according to the VAS was 7 (range: 5-8) before ozone treatment, 4 (range: 2-6) at the end of ozone treatment (p = 0.004), 5.5 (range: 1.8-6.3) 3 months after the end of ozone treatment (p = 0.008), and 6 (range: 2.6-6.6) 6 months after the end of ozone treatment (p = 0.008). The toxicity grade, according to the Common Terminology Criteria for Adverse Events (CTCAE v.5.0), improved in half of the patients. Conclusion: This report shows that most patients obtained clinically relevant and long-lasting improvement in chronic pain secondary to CIPN after treatment with ozone. These observed effects merit further research and support our ongoing randomized clinical trial (NCT04299893).

Factors associated with patient empowerment in Spanish adults with type 2 diabetes: A cross-sectional analysis.

OBJECTIVE: The aim of the present study is to identify factors associated with patient empowerment in people living with type 2 diabetes mellitus (T2DM) in the Canary Islands (Spain). METHODS: Secondary cross-sectional analysis was carried out of data obtained in the INDICA study: A 24-month cluster randomized-controlled trial evaluating the effectiveness of educational interventions supported by new technology decision tools for T2DM patients. Sociodemographic variables, clinical data (years since diagnosis, glycated haemoglobin level, creatine, triglycerides, waist hip index, body mass index and number of comorbidities), diabetes knowledge (DIATEK), affective outcomes (Beck Depression Inventory-II, the State subscale of the State-Trait Anxiety Inventory and The Diabetes Distress Scale) and diabetes-related quality of life (The Audit of Diabetes-Dependent Quality of life) were assessed as potential correlates of patient empowerment, assessed using the Diabetes Empowerment Scale-Short Form. Multilevel mixed linear regression models on patient empowerment were developed. RESULTS: The analysis included the baseline data of 2334 patients. Results showed that age (B = -0.14; p < .001), diabetes knowledge (B = 0.61; p < .001) and state-anxiety (B = -0.09; p < .001) are significantly associated with patient empowerment. Sex, education level, living alone, employment status, country of birth, time since diagnosis, number of comorbidities, glycated haemoglobin level, depression and distress were not independently associated with patient empowerment in the multivariate analyses. CONCLUSION: Younger age, lower state-anxiety and greater diabetes-specific knowledge are important correlates of patient empowerment. In line with the results of the INDICA study, interventions based on patient-centred care might be effective in improving patient empowerment in adults with T2DM. Understanding the factors associated with empowerment may help clinicians and policymakers to identify high-risk groups, prioritize resources and target evidence-based interventions to better support people with T2DM to be actively involved in their own care. PATIENT OR PUBLIC CONTRIBUTION: Patients with T2DM were actively involved in the design of the INDICA study. Two patient associations were included as part of the research team and actively participated in designing the interventions and selecting outcome measures.

Clinical outcomes and lung ultrasound findings in COVID-19 follow up: Calm comes after the storm?

INTRODUCTION: There is still an undiscovered territory about the sequelae and lung ultrasound (LUS) findings after SARS-CoV2 acute infection. This study aims to investigate the post-COVID period from a clinical, psychosocial, and radiological point of view, analyze LUS on COVID-19 follow-up and detect whether these outcomes are related to the patient situation. METHODS: We conducted an observational study on patients diagnosed with SARS-CoV2 pneumonia and admitted to the University Hospital of La Candelaria (Tenerife, Spain) from 1st March to 31st August 2020. We performed a descriptive analysis on post-COVID manifestations, LUS score, health-related quality of life measured through the Euroqol 5D-5L questionnaire, and lung function parameters on follow-up, and we compared these variables to the outcomes during the hospital admission. RESULTS: 77 patients were included; the mean age was 57 years and the follow-up mean time from hospital discharge was 16 weeks. 87% of the cases had symptoms on follow-up, the most common was dyspnea (65%); these manifestations were more frequent in females (p = 0,015). 76,5% of the cases had lung aeration alteration in LUS on follow-up; lower PaO2/FiO2 and greater CRP and IL-6 levels on admission were related to LUS score ≥1. CONCLUSIONS: Almost 90% of the patients had persistent symptoms after 16 weeks of hospital discharge due to COVID-19, the most common manifestation presented was dyspnea. Altered lung aeration pattern in LUS was observed on more than 70% of the patients on follow-up.